Kornimate/medical-research-clean huggingface dataset:
alefacept for chronic graft versus host disease

Conditions: Resistant Chronic GVHD

Summary: alefacept (amevive®) is an immunosuppressive dimeric fusion protein that consists of the extracellular cd2-binding portion of the human leukocyte function antigen-3 (lfa-3) linked to the fcof igg1. alefacept is produced by recombinant dna technology in a chinese hamster ovary (cho) mammalian cell expression system. it was shown to interfere with lymphocyte activation. alefacept was evaluated in two randomized, double-blind, placebo-controlled studies in adults with chronic plaque psoriasis. each course consisted of once-weekly administration for 12 weeks of placebo or alefacept. the response to alefacept was significantly better in both studies. in both studies, onset of response to alefacept treatment (defined as at least 50% reduction of baseline psoriasis area and severity index (pasi)) began 60 days after the start of therapy. with one course of therapy, the median duration of response (defined as maintenance of a 75% or greater reduction in pasi) was 3.5 months for alefacept treated patients and 1 month for placebo-treated patients. most patients who had responded to either alefacept or placebo maintained a 50% or greater reduction in pasi through the 3-month observation period. graft versus host disease (gvhd) is the most ominous side effect of allogenic stem cell transplantation (sct). it causes severe inflammatory process, which is usually located to the skin, gut and liver. treatment of gvhd consists of various immuno-suppressive and immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc. these drugs unfortunately can also cause severe immunologic failure that makes the patient prone to infection and malignancy, and other medication-specific side effects. in spite of this effect on the immune system, not all of the patients achieve control of gvhd, which usually rapidly leads to death. despite the use of innovative immunosuppressive modalities, the prognosis of steroid resistant gvhd is usually poor. in the following study we will evaluate the effect of alefacept on steroid unresponsive cgvhd.


Eligibility criteria:
inclusion criteria: * no age limit * resistant chronic gvhd exclusion criteria: * not fulfilling any of the inclusion criteria * active life-threatening infection * inability to comply with study requirements. * known hypersensitivity to alefacept. * active malignant disease

Keywords: gvhd
healthy transitions in late stage kidney disease

Conditions: Chronic Kidney Disease

Summary: improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a nephrologist's routine patient care.


Eligibility criteria:
inclusion criteria: * stage 4-5 chronic kidney disease (ckd), defined as estimated glomerular filtration rate (egfr) between 0-30 ml/minute * 18 years of age or older exclusion criteria: * cognitive impairment that is clinically apparent
prospective randomized study of ptc and eus-guided drainage of the bile duct

Conditions: Jaundice

Summary: at this time, endoscopic retrograde cholangiopancreatography (ercp) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. when ercp fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (ptbd) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. recent developments in interventional endoscopic ultrasonography (eus) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. more recently were described the possibility to realize eus-guided biliary drainage, through the duodenal or the gastric wall. advantages of the eus-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). this technique is actually an alternative to ptbd. in comparison of the ptbd, eus-guided route seems to have less morbidity and to avoid external biliary drainage. indeed, the morbidity rate of the percutaneous biliary drainage and the eus-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. however, none study compare prospectively both techniques. aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.


Eligibility criteria:
inclusion criteria: * age \>= 18 * karnofsky \>= 50% * biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography * signed informed consent exclusion criteria: * isolated biliary stenosis of right hepatic canal * percutaneous biliary drainage \< 10 days * laparotomy \< 10 days * contra-indication to the procedure * pregnant women

Keywords: stenosis of biliary ways
the reducing risk study

Conditions: Insomnia; Delayed Sleep Phase

Summary: the present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.


Eligibility criteria:
inclusion criteria: exclusion criteria: * any current psychiatric illness * currently use of medications or herbs with known effects on sleep * hospitalization for substance use or suicide within the past 12 months * known sleep apnea * unstable major medical conditions * current psychotherapy for depression, anxiety or sleep health deficits
quantitation of bacteria associated with severe periodontitis by real -time pcr following application of diode laser

Conditions: Periodontal Pocket

Summary: 1. primary objective to measure the gingival crevicular levels of a.actinomycetemcomitans and p.gingivalis after intra-pocket application of diode laser in severe periodontitis (stage 3 grade c) patients. 2. secondary objective to compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis (stage 3 grade c) patients. 3. to measure clinical parameters probing depth,attachment loss and mobility grade


Eligibility criteria:
inclusion criteria: 1. patients of both sexes having severe periodontitis (stage 3 grade c) with interdental clinical attachment loss (cal) ≥ 5. 2. patients' age between 15 and 35 years old with rapid bone loss showed by radiograph. 3. systemically healthy patients. 4. radiographic bone loss extending to middle or apical third of root. 5. probing depth (pd) ≥ 6 mm. exclusion criteria: 1. use of antibiotics during the last 3 months. 2. pregnancy. 3. any systemic condition that might affect the study. 4. use of mouthwash containing antimicrobials during the previous 3 weeks. 5. smoking.
cognitive behavior therapy vs exposure in vivo in the treatment of panic disorder with agoraphobia

Conditions: Panic Disorder With Agoraphobia

Summary: panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety disorders. although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research, studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences. therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia.

anxiety disorders are the most common group of mental illnesses, with lifetime prevalence estimates ranging between 10-30% (kessler et al 2007). they are an economic burden on society and the sixth largest cause of disability globally (baxter et al 2014; fineberg et al 2013). suffering from an anxiety disorder is distressing, with affected individuals reporting adverse effects on quality of life comparable to sufferers of major depressive disorder, and in excess of the population norm (mendlowicz and stein 2000). panic disorder with agoraphobia is especially prevalent and one of the most handicapping anxiety disorders. although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research (sanchez-meca, rosa-alcazar, marin-martinez \& gomez-conesa, 2010), studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences. therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia. participants suffering from panic disorder, agoraphobia receive exposure-based treatment with elements of cognitive restructuring (cbt-group) or without such elements (exposure-only group) delivered according to treatment manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. both treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises. in the cbt group identification and correction of maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment package.

Eligibility criteria:
inclusion criteria: * diagnosis of panic disorder with agoraphobia by trained clinician using a structured interview * the anxiety disorder is considered to be the patient's main current problem * age between 18 and 65 years * the patient has agreed to participate in the study exclusion criteria: - diagnosis of bipolar disorder, psychotic disorder, alcohol/substance abuse or dependency (within past 3 months), prominent risk of self-harm, organic mental disorder; concurrent psychotherapeutic or psychopharmacological treatment

Keywords: cognitive behavior therapy exposure in-vivo panic disorder with agoraphobia
the evaluation of pharmacokinetic/pharmacodynamic characteristics and safety of qdx in healthy korean male subjects

Conditions: Migraine

Summary: to evaluate pharmacokinetic/pharmacodynamic characteristics and safety of qdx after single oral administration in healthy korean male subjects


Eligibility criteria:
inclusion criteria: * participants who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent which is confirmed from irb. * healthy male participants aged between 19 and 45 years at screening * those whose body weight is over 50kg, and bmi is between 18.0 and 27.0 * participants who have demonstrated at least a 100 percent (%) increase in dermal blood flow in 30 minutes after capsaicin challenge as part of the screening procedures. exclusion criteria: * those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of those diseases * those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing topiramate etc.) * those who have a hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome * those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin is applied
efficacy of prazosin versus placebo associated with peg-interferon alpha 2b and ribavirin in chronic hepatitis c with genotype 1 or 4 and severe fibrosis

Conditions: Hepatitis C, Chronic; Fibrosis

Summary: viral hepatitis c prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. the study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis c and severe fibrosis.

treatment of hepatitis c with interferon and ribavirin has a virological effect. viral hepatitis c prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. in vitro studies of prazosin suggest an effect against hepatic fibrosis, but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis c infection is unknown. the purpose of this multicentric national study is to compare the effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or not (placebo). 112 patients with a viral hepatitis c, genotype 1 or 4, and severe fibrosis, will be randomly assigned to one of two treatment groups: peg-interferon alpha 2b and ribavirin, with prazosin or with placebo. peg-interferon alpha 2b will be administered once a week (1.5 micro g per kg) during 48 weeks, ribavirin 1,000 to 1,200 mg per day (according to weight) during 48 weeks, prazosin/placebo 5 mg (2 pills) per day during 96 weeks. evaluation will be done at 96 weeks. the primary end-point is the proportion of patients presenting a decrease of fibrosis. secondary end-points are other criteria of histological response, virological response, biochemical response.

Eligibility criteria:
inclusion criteria: * chronic viral hepatitis c, genotype 1 or 4 * fibrosis f3 or f3-f4, assessed by the scoring metavir system * initial treatment against hcv exclusion criteria: * psychiatric pathology * alcool consummation * pregnancy or plan of pregnancy * breastfeeding

Keywords: hepatitis c, chronic fibrosis interferon alfa-2b ribavirin prazosin
deposition of inhaled prolastin in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: the objective of this trial is to determine the optimal region of the lung for depositing prolastin (alpha-1 antitrypsin; aat) by inhalation in order to treat cystic fibrosis (cf). the akita® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one to one randomization. the study will measure how much of the activity of the enzyme elastase is inhibited by aat.

the optimum deposition site (bronchial or peripheral) in cf patients for aat will be investigated by measuring several parameters in induced sputum. the study will start with a 2 week run-in period in which the planned 60 patients inhale isotonic saline once daily. this period is followed by a 4 week treatment period where 30 patients inhale aat for peripheral deposition and 30 patients inhale aat for bronchial deposition. six patients in each group will be asked to collect spontaneous sputum at home. twenty-five milligrams of aat will be deposited at one of the two target sites using the akita® device. the inhalation should take place in the evening between 18.00 and 23.00 h. patients will inhale saline once daily for 2 weeks (run-in period) followed by 4 weeks of once daily inhalation of aat. induced sputum will be collected at visits to the clinic at the start of the run-in, at the start of aat treatment, and at 2 and 4 weeks after the start of aat treatment.

Eligibility criteria:
inclusion criteria: * patient with diagnosis of cf * age \>= 8 years * forced expiratory volume at one second (fev1) \> 25 % of predicted value * free elastase activity checked at visit 1 must be positive (free elastolytic activity in the sample, 2 standard deviations above of the negative blank samples in the assay.) . * patient must be positive at least 3 times for pseudomonas in the last 2 years * patient must be positive for pseudomonas at visit 1 * patient must be able to perform reliable spirometry * patient must be on stable concomitant therapy at least 2 weeks prior to visit 1 and during the study * written informed consent of the patient or legal representative(s) exclusion criteria: * fev1 \< 25% of predicted value post-bronchodilator * history of lung transplant * any lung surgery within the past 2 years * on any thoracic surgery waiting list * severe concomitant disease (serious malignant disease, congestive heart failure new york heart association (nyha) iii/iv, cor pulmonale with the need of oxygen therapy) * severe liver cirrhosis with ascites, hypersplenism or grade iii/iv esophageal varices. * known selective immunoglobulin a (iga) deficiency with known antibody against iga (anti-iga antibody) * active pulmonary exacerbation within the 4 weeks prior to screening * current smoking * pregnancy or lactation * women of child-bearing age without adequate contraception * any medical condition which the investigator feels will prohibit the patient from completing the trial * participation in another clinical trial within 30 days prior to inclusion at visit 1
follow up of an online hearing support for first-time hearing aid users

Conditions: Hearing Loss; Hearing Impairment; Hearing Disorders

Summary: the main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.

investigation of the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids. the goal is also to assess changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.

Eligibility criteria:
inclusion criteria: * people who have participated in nct06051968 are automatically enrolled to participate in the follow-up according to the study protocol.
psychobiological evaluation of the army resilience training

Conditions: Psychological Stress; Psychological Adaptation

Summary: this study evaluates the influence of a resilience training on psychobiological factors which are related to stress and resilience in young healthy male cadets. half of participants will join in the resilience training, while the other half take part in a control-training (diversity management training).

the resilience training (army resilience training / art) is a stress prevention program based on well established methods from cognitive behavioral therapy (cbt) and positive psychology adapted for the needs of swiss armed forces. art is designed for healthy subjects to learn how to get over strain. diversity management training (dmt) aims to promote social skills and acts as control condition. dmt is part of the military training but not mandatory for the study population.

Eligibility criteria:
inclusion criteria: * military cadets of the swiss army infantry officers school inf os 10-1/17 exclusion criteria: * no
amniotic membrane for donor site healing

Conditions: Burns

Summary: the purpose of this study is to compare the effectiveness of applying amniotic membrane dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. this study will enroll ten participants who undergoing a split thickness skin graft procedure with two or more donor sites. the amniotic membrane will be applied to one donor site and a dressing of xeroform and gentamicin will be applied to another other donor site. each participant will receive both types of dressing and will serve as their own control. postoperative follow up will follow standard of care, regardless of the dressing type. dressings will be removed on postoperative day 4 and participants will return to be re-examined one week after being discharged from the hospital.

the use of amniotic membrane in the treatment of wounds has been employed for almost 100 years, with reports of it being used in skin grafting for burns and ulcers in 1913. this study will investigate the use of amniotic membrane as a donor site dressing (the area where skin is removed to be transplanted to the recipient site). donor sites are often a significant cause of postoperative pain for patients who have undergone skin grafts. furthermore, donor sites that fail to re-epithelialize or scar may require additional excision and skin grafting on the donor site itself. there is a paucity of literature in the united states regarding the use of amniotic membrane as a donor site dressing, however, studies from other countries have demonstrated an increase in patient comfort and a faster time to re-epithelialization. inherent to amniotic membrane that makes it an ideal dressing include the presence of extracellular matrix components create integrity, epithelial cells participate in the healing process, and defensins confer antibacterial properties. mimedx produces amniofix® which is a dehydrated preserved amniotic membrane that will be used in the dressing of our donor sites in contrast to gentamicin and xeroform based dressings. this study will see if patients have improved cosmetic outcomes, less postoperative pain and a faster time to re-epithelialization at the donor site treated with amniotic membrane compared to the standard of care.

Eligibility criteria:
inclusion criteria: * undergoing a split thickness skin graft procedure with two or more donor sites exclusion criteria: * less than 18 years of age

Keywords: skin graft
effect of ultrasound-guided piriformis muscle corticosteroid injection versus extracorporeal shock wave therapy for piriformis syndrome: a randomized control trial

Conditions: Piriformis Syndrome; Corticosteroid Injection; Extracorporeal Shockwave Therapy; Therapeutic Exercise

Summary: in this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis coticosteroid injection in treatment of ps.

piriformis syndrome (ps) is one of the common etiology of low back pain. the cause of ps is due to myofascial syndrome of piriformis muscle, leading to piriformis muscle spasm, string-like taut band, and trigger point. consequently, it may compresses the sciatic nerve which arise from sciatic notch and passes under the piriformis muscle. conservative treatment of ps includes therapeutic exercise, diathermy, and local steroid injection. among them, as radiology techniques advance, ultrasound-guided piriformis injection becomes popular for diagnosis block and treatment. nowadays, extracorporeal shockwave therapy has widely applied in musculoskeletal disease such as plantar fasciitis, tennis elbow, and calcific tendinitis of the shoulder. however, to the investigators best knowledge, there is no study comparing the therapeutic effect between local steroid injection and shockwave. in this study, the investigators aim to compare the effect of extracorporeal shockwave therapy with ultrasound-guided piriformis corticosteroid injection. this is a randomized controlled trial. 70 participants will be randomly divided into shockwave group and injection group. the participant in the shockwave group will receive one time extracorporeal shockwave therapy, and injection group will receive one time ultrasound-guided piriformis muscle corticosteroid injection. after the intervention, participant in both groups will receive home-based stretch exercise. evaluation will be performed at baseline, 1 week, and 5 weeks after intervention. outcome measures include the pain visual analog scale (vas), hip range of motion, change of pressure pain threshold, and oswestry disability index (odi).

Eligibility criteria:
inclusion criteria: 1. age from 20 to 80 2. unilateral buttock involvement without leg pain or paresthesia 3. duration of symptoms ≥1 month 4. positive trigger point or taut band at piriformis muscle, confirmed by palpation and ultrasound examination 5. positive fair (flexion, adduction, internal rotation) test 6. positive piriformis resistive test (patient actively abducts and/or externally rotates the hip while the examiner resists these movements exclusion criteria: 1. having received hip, pelvis, or lumbar spine surgery 2. low back pain or buttock pain due to lumbosacral spine, hip or pelvis lesion other than piriformis syndrome 3. having received shock wave therapy or corticosteroid injection for buttock pain within the past one month 4. neurologic deficit in in the lower limbs 5. history of drug allergy to local anesthetics or corticosteroids 6. pregnancy

Keywords: piriformis syndrome ultrasound-guided intervention corticosteroid injection extracorporeal shockwave therapy therapeutic exercise